Alcohol DrinkingNCT05522075
Reducing Blood Pressure in Mid-life Adult Binge Drinkers
A study testing Exercise Training and Alcohol Abstinence Intervention in people with Alcohol Drinking and Binge Drinking, run by The University of Texas at Arlington at 1 site in United States.
Trial summary
This study has two phases: Phase 1 is to examine blood pressure, microvascular function, and sympathetic nerve activity in mid-life adult binge drinkers vs. alcohol abstainers/moderate drinkers. Read more about this study
- Who is it for?
- Ages 50 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Binge Drinking, Blood Pressure
- What is being tested?
- Exercise Training and Alcohol Abstinence Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2022to 30 Apr 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women (50-64 years of age) who do not drink alcohol, who drink at moderate levels, or who binge drink
- Female subjects will be postmenopausal (i.e., cessation of menses for ≥1 yr).
- Subjects who can speak and understand English.
Who cannot join
- a history of diabetes, cardiovascular disease, liver, or renal disease
- current or history of smoking and illicit drug use
- blood pressure ≥160/100 mm Hg
- other known traditional cardiovascular disease risks: obesity (BMI≥35 kg/m2), or hyperlipidemia (total cholesterol>230 mg/dl and/or LDL cholesterol>160 mg/dl)
- active infection (in the past 2 months)
- a history of seizures, cancer, or inflammatory disease (i.e., gout or rheumatoid)
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- unstable body weight (>5% change during the past 6 months)
- regular aerobic exercise training (i.e., they engage in 30 min of structured aerobic exercise at least 3 times per week)
- current use of hormone replacement therapy (i.e., estrogen, progesterone, and testosterone)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas at Arlington
Arlington, Texas, 76010
Chueh-Lung Hwang, PhD, PT, 817-272-9722, chuehlung.hwang@uta.edu
About this study
Official title: Reducing Blood Pressure in Mid-life Adult Binge Drinkers: the Role of Microvascular Function and Sympathetic Activity
This study has two phases:
Phase 1 is to examine blood pressure, microvascular function, and sympathetic nerve activity in mid-life adult binge drinkers vs. alcohol abstainers/moderate drinkers.
Phase 2 is to examine the effect of 8-week aerobic exercise training on blood pressure, microvascular function, and sympathetic nerve activity in mid-life adult binge drinkers
Read the detailed description
During phase 1, we will measure blood pressure, microvascular function, and sympathetic nerve activity (baseline assessment) in mid-life adult binge drinkers, alcohol abstainers, and moderate drinkers. Only mid-life adult binge drinkers will enter Phase 2 and be randomized to the exercise training group and non-exercise control group. After 8 weeks of intervention, we will re-measure blood pressure, microvascular function, and sympathetic nerve activity (post-intervention assessment) in mid-life adult binge drinkers.
- Conditions
- Alcohol Drinking, Binge Drinking, Blood Pressure, Alcohol Abstinence, Aging, Lifestyle Factors
- Being tested
- Exercise Training, Alcohol Abstinence Intervention
- Keywords
- Exercise training, High-intensity interval training, Midlife adults, Middle-aged, Microvascular function, Sympathetic nerve activity
- Medical subject headings
- Alcohol Drinking, Binge Drinking, Alcohol Abstinence, Aneurysm, Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TrainingBehavioural
Subjects will be asked to perform exercise training (high-intensity interval training) under supervision, 3 times per week for 8 weeks. Each training session will last 40 minutes and will consist of 10-minute warm up at 70% of maximal heart rate (HRmax), four 4-minute intervals at 90% of HRmax with 3-min active recovery at 70% of HRmax and 5-minute cool down at 70% of HRmax.
Alcohol Abstinence InterventionBehavioural
Subjects will be asked to abstain from alcohol for 8 weeks. Education materials and bi-weekly consultations will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | Binge drinkers who have been assigned to exercise group will receive baseline assessment, 8-week exercise training plus alcohol abstinence intervention, and post-intervention assessment. Receives: Behavioral: Exercise Training; Behavioral: Alcohol Abstinence Intervention |
| Non-exercise Group | Active comparator | Binge drinkers who have been assigned to non-exercise group will receive baseline assessment, 8-week alcohol abstinence intervention, and post-intervention assessment. Receives: Behavioral: Alcohol Abstinence Intervention |
| Alcohol abstainer/moderate drinker group | No intervention | Alcohol abstainer/moderate drinker will complete baseline assessment only and will not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of high-intensity interval training
Recruitment capacity (e.g., how many subjects respond and enter to the study or reasons of refusal), resulting subject characteristics, the number of exercise session attended, and the number of dropouts
Measured: Through out the study participation (~3 months)
Secondary outcomes (5)
Changes in microvascular function
A small amount of fat will be taken form the buttock. Small vessels will then be found in the fat and their sizes in response to various flows and chemical agents will be measured.
Measured: Baseline and after an 8-week intervention
Changes in sympathetic activity
A small electrode will be inserted into the back of the knee to record nerve activity (bursts/min).
Measured: Baseline and after an 8-week intervention
Changes in urine catecholamine levels
Urine samples will be collected for 24 hours to measure norepinephrine levels (ug/g)
Measured: Baseline and after an 8-week intervention
Changes in blood pressure
Systolic and Diastolic blood pressure will be measured at rest and for 24 hours.
Measured: Baseline and after an 8-week intervention
Changes in alcohol intake
Questionnaires will be used to determine alcohol intake.
Measured: Baseline and after an 8-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start21 Nov 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Arlington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Chueh-Lung Hwang, PhD, Principal investigator, University of Texas at Arlington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522075
- Sponsor's protocol ID
- 2200-0189
- Other IDs
- 4R00AA028537-03
- Status last verified
- May 2026
- First submitted
- 22 Aug 2022
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will submit to the NIMH Data Archive human subjects' data that were collected as part of the "Research Project" including microvascular function, sympathetic activity, and blood pressure. These data will be made accessible to authorized users for the purpose of scientific investigation, scholarship or teaching, or other forms of research and research development.